Associate Consultant Scientist TS/MS

Mô tả công việc

Leverage prior technical experiences and capabilities to be Technical Services and Manufacturing Science Product Steward.Develop, launch, and validate dry product manufacturing processes such that they maintain a constant state of validation, control, and capability. Key Objectives/Deliverables: Work with Chemistry and Manufacturing Controls personnel to develop the drug product control strategy, including process and operating parameters, for new drug products in line with Good Manufacturing Practices and Quality by Design principles in order to assure process control and capability and optimal product quality.Work with Regulatory and the Chemistry and Manufacturing Control personnel to develop, file, and defend regulatory commitment documents for drug product.Work with drug substance colleagues to understand and align with drug product and drug substance to ensure product control and capability.Own the development, writing, and maintenance of master formulas/batch records (for commercial and clinical trial/development lots), Process Flow Documents, and other technical support reports and documentation.Work with Product Research and Development to develop functional raw material/component specifications and to understand and control key sources of material variability.Lead the development and validation/qualification of process or raw material improvements/changes.Investigate and resolve process/product issues deviations and author reports assessing the impact of same.Proactively reduce the likelihood of such issues.Coach/mentor/educate and support other technical support colleagues as well as other inquiries related to drug product.